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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 25740011090
Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Numbness (2415); Ambulation Difficulties (2544)
Event Date 04/15/2021
Event Type  Malfunction  
Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from healthcare provider via a manufacturer representative regarding a patient who was implanted with a spinal product type for proximal junctional kyphosis. It was reported that set screws on both sides of s2ai backed out after the operation. Both were completely backed out from the screw head. At the moment, follow-up was scheduled, and the schedule for reoperation was undecided. The patient could not run or walk due to sudden numbness. X-ray findings revealed that the left and right s2ai set screws had came off. It was revision surgery. In the initial operation on (b)(6) 2016, fixed to t10-l4 with l1 vertebral column resection(vcr) due to l 1 fracture. In the second operation on (b)(6) 2019,extension of fixing due to broken rod or something. Extended to t10-s2ai. Reinforcement using domino and cover for broken part of rod. In the third operation ((b)(6) 2019), only the ba set screw that was inserted into s2ai on the right came off (disengaged), so it was expanded with surgical precision and the set screw was replaced. The breakoff had also been completed without any problems. In the fourth operation ((b)(6) 2020). Reinforcement operation for rod replacement and additional intervertebral fusion due to rod breakage. At this time, the ba set screw inserted into the s2ai on the right had also came off. Since rod was replaced, the set screw had also been changed to a new one. In the fifth operation ((b)(6) 2021) pjk occurred, the rod must had been broken, so rod was replaced, and reinforcement operations such as fixed extension to t7 were performed. The s2ai screw was also replaced and various set screws were also replaced with new ones. On (b)(6) 2021, the patient could not run or walk due to sudden numbness.

 
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Brand NameCD HORIZON BALLAST SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11805115
MDR Text Key250665296
Report Number1030489-2021-00599
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK153442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number25740011090
Device Catalogue Number25740011090
Device LOT NumberCA15K164
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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